PMA supplement

N17786 S009: SOFTLENS CLEANING & DISINFECTING SOLN.

FDA PMA supplement · Advanced Medical Optics, Inc.

Key facts

Original PMA N17786
Supplement number S009
Trade name SOFTLENS CLEANING & DISINFECTING SOLN.
Generic name Accessories, soft lens products
Applicant Advanced Medical Optics, Inc.
Product code LPN
Received date May 6, 1982
Decision date Jul 16, 1982

At a glance

  • No Expedited review granted
  • No Approval order on file
  • No Summary of safety and effectiveness on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMA supplements

A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.

Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date:

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